Sayaka Fukura

Deputy Head of the Clinical Operations Division
CMIC

Sayaka Fukura is a distinguished professional with an extensive background in clinical research and development. She is primarily affiliated with the Tokyo-based CMIC Group. She has played an integral role in clinical trials and project management for over two decades.
 
After completing her graduate studies in science, Sayaka transitioned into pharmaceutical roles before joining the CMIC Group in 2004. Throughout her tenure, Sayaka has advanced through various directorial positions, showcasing her expertise in cardiovascular medicine, hematology, respiratory medicine, and regenerative medicine.
 
Since 2016, Sayaka has led the regenerative medicine monitoring team at CMIC, establishing herself as a specialist in developing regenerative medical products and therapies for rare diseases. She has overseen multiple clinical trials in cell and gene therapy, demonstrating her meticulous approach to monitoring and project management in these cutting-edge fields of medicine.



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Speech title & Synopsis

From Concept to Clinic: Advancing Rare Disease Projects

Established as Japan's first Contract Research Organization (CRO), CMIC Group has emerged as a leader in clinical research and development. With a workforce of over 1,200 clinical research associates (CRAs) throughout Japan, we offer capabilities that extend beyond traditional monitoring services. We pride ourselves on our team of highly experienced regulatory consultants who possess profound expertise and insight. These consultants collaborate with our clinical operations team from the earliest stages of development, fostering an environment that significantly improves the likelihood of successful project outcomes within Japan's unique regulatory landscape.
 
CMIC Group also encompasses a broader spectrum of services, including non-clinical research facilities and pharmaceutical manufacturing plants through our affiliated companies. This comprehensive infrastructure enables us to provide end-to-end solutions, particularly excelling in developing therapies for rare diseases and regenerative medical products. By integrating these diverse resources, we contribute to the advancement of innovative medical treatments that address unmet needs in these specialized areas.
 
In this presentation, we will showcase our achievements and outline the critical success factors derived from our extensive experience with contracted projects and collaborative research initiatives. Through illustrating our strategic approach and detailing specific case studies, we hope to provide valuable insights into the mechanisms that underpin our accomplishments. Our methodology emphasizes collaboration, regulatory foresight, and operational excellence, underscored by our commitment to driving progress in the fields of rare and regenerative medicine.